1. Field of the Invention
This invention is in the field of cryosurgical apparatus used to cool very small portions of biological tissue to very low temperatures, by insertion of a small diameter, flexible catheter to the treatment area.
2. Background Information
In the field of medicine, it may be desirable to be able to cool miniature discrete portions of biological tissue to very low temperatures in the performance of cryosurgery, without substantially cooling adjacent tissues of the organ. While miniature refrigeration systems may have application in other fields, the present invention provides an apparatus which is uniquely suited for the field of miniature cryosurgery.
Cryosurgery has become an important procedure in medical, dental, and veterinary fields. Particular success has been experienced in the specialties of gynecology and dermatology. Other specialties, such as neurosurgery and urology, could also benefit from the implementation of cryosurgical techniques, but this has only occurred in a limited way. Unfortunately, currently known cryosurgical instruments have several limitations which make their use difficult or impossible in some such fields. Specifically, known systems are not optimally designed to have sufficient precision and flexibility to allow their widespread use endoscopically and percutaneously.
In the performance of cryosurgery, it is typical to use a cryosurgical application system designed to suitably freeze the target tissue, thereby destroying diseased or degenerated cells in the tissue. The abnormal cells to be destroyed are often surrounded by healthy tissue which must be left uninjured. The particular probe or other applicator used in a given application is therefore designed with the optimum shape and size for the application, to achieve this selective freezing of tissue. Where a probe is used, the remainder of the refrigeration system must be designed to provide adequate cooling, which involves lowering the operative portion of the probe to a desired temperature, and having sufficient power or capacity to maintain the desired temperature for a given heat load. The entire system must be designed to place the operative portion of the probe at the location of the tissue to be frozen, without having any undesirable effect on other organs or systems.
Currently known cryosurgical systems typically use liquid nitrogen or nitrous oxide as coolant fluids. Liquid nitrogen is usually either sprayed onto the tissue to be destroyed, or it is circulated to cool a probe which is applied to the tissue. Liquid nitrogen has an extremely low temperature of approximately 77 K, and a high cooling capacity, making it very desirable for this purpose. However, liquid nitrogen typically is allowed to evaporate and escape to the atmosphere during use, requiring the continual replacement of storage tanks. Further, since the liquid is so cold, the probes and other equipment used for its application require vacuum jackets or other types of insulation. This makes the probes relatively complex, bulky, and rigid, and therefore unsuitable for endoscopic or intravascular use. The need for relatively bulky supply hoses and the progressive cooling of all the related components make the liquid nitrogen instruments less than comfortable for the physician, as well, and they can cause undesired tissue damage.
A nitrous oxide system typically achieves cooling by pressurizing the gas and then expanding it through a Joule-Thomson expansion element, such as a valve, orifice, or other type of flow constriction, at the end of a probe tip. Any such device will be referred to hereinafter simply as an "expansion element". The typical nitrous oxide system pressurizes the gas to 700 to 800 psia., to reach practical temperatures of no lower than about 190 K to 210 K. Nitrous oxide systems are not able to approach the temperature and power achieved by the nitrogen systems. The maximum temperature drop that can be achieved in a nitrous oxide system is to 184 K, which is the boiling point of nitrous oxide. The nitrous oxide system does have some advantages, in that the inlet high pressure gas is essentially at room temperature until it reaches the Joule-Thomson element at the probe tip. This eliminates the need for insulation of the system, facilitating miniaturization and flexibility to some extent However, because of the relatively warm temperatures and low power, tissue destruction power is limited. For many such applications, temperatures below 184 K are desirable. Further, the nitrous oxide must typically be vented to atmosphere after passing through the system, since affordable compressors suitable for achieving the high pressures required are not reliable and readily commercially available.
In most Joule-Thomson systems, single non-ideal gasses are pressurized and then expanded through a throttling component or expansion element, to produce isenthalpic cooling. The characteristics of the gas used, such as boiling point, inversion temperature, critical temperature, and critical pressure determine the starting pressure needed to reach a desired cooling temperature. Joule-Thomson systems typically use a heat exchanger to cool the incoming high pressure gas with the outgoing expanded gas, to achieve a higher drop in temperature upon expansion and greater cooling power. For a given Joule-Thomson system, the desired cooling dictates the required heat exchanger capacity. Finned tube heat exchangers have been used, but these must be relatively long and bulky to achieve the required cooling, preventing their use in flexible cryosurgical catheters. Smaller heat exchangers have also been known, constructed of photo-etched glass plates. These heat exchange systems are still in the range of several centimeters square in size, making them still too bulky for use in flexible cryosurgical catheters. Further, these heat exchangers are planar and difficult to incorporate into tubular catheters. In these medical applications, the dimensions of the components must be less than approximately 3 mm. in width to allow incorporation into a catheter, and preferably less than 15 mm. in length to allow sufficient flexibility.
Where a small heat exchanger is placed near the distal end of a flexible catheter, the heat exchanger will necessarily be exposed to the thermal environment in that region of the patient's body. The surrounding biological tissue can impose a significant additional head load on the refrigeration system, through the heat exchanger. The heat exchanger can not normally be insulated from the thermal effects of the surrounding biological tissue, because of space limitations at that point. The additional heat load imposed on the refrigeration system by the biological tissue near the point of cooling will limit the performance of the heat exchanger, by warming both the high pressure and low pressure gas streams passing through the heat exchanger. Furthermore, the biological tissues in the vicinity of the heat exchanger can receive undesirable cooling by being exposed to the virtually uninsulated heat exchanger.
Heat exchanger requirements can be reduced somewhat by pre-cooling the gases prior to the probe tip heat exchanger. This can be done by incorporating a Peltier device in the flow path prior to the probe tip heat exchanger. Gas flowing through a heat exchanger on the surface of the cold side of the Peltier device would be cooled prior to reaching the heat exchanger near the catheter tip. Alternatively, the inlet high pressure stream could be split so that a portion of the stream could be diverted and expanded to cool the remaining portion of the inlet stream prior to reaching the heat exchanger at the catheter tip.
A dramatic improvement in cooling in refrigeration systems can be realized by using a mixture of gasses rather than a single gas. For example, the addition of hydrocarbons to nitrogen can increase the cooling power and temperature drop for a given inlet pressure. Further, it is possible to reduce the pressure and attain performance comparable to the single gas system at high pressure. Similar to single gas systems, these mixed gas systems have heat exchanger requirements and they are limited in their miniaturization potential by the size of the heat exchanger. The improvement in cooling performance realized by mixed gas systems is very desirable for flexible cryosurgical catheter systems.
Some mixed gas systems have been designed where high pressure is not a major concern, and where bulky high efficiency heat exchangers can be used, but they are typically used in defense and aerospace applications. The glass plate heat exchangers mentioned above are used in some such systems, and these systems sometimes require pressures of 1200 psia. In cryosurgical catheter applications, pressures above approximately 420 psia are undesirable for safety reasons, and because the devices exhibit poor longevity, high cost, and poor reliability. Further, a catheter which can withstand the higher pressures must typically be made of a material which is less flexible than is often desirable in a catheter. Still further, any heat exchanger which is used in a flexible cryosurgical catheter must have a width or diameter no greater than about 3 mm., and a length of no more than about 15 mm.
Specifically, it would be desirable to develop a long, slender, flexible cryosurgical catheter, for example, a transvascular cardiac catheter, which can operate at relatively low pressure while achieving the necessary cooling power to destroy biological tissue. Cardiac catheters must be very slender, in the range of less than 5 mm., and they must exhibit considerable flexibility, in order to be inserted from an access point in a remote blood vessel into the heart. A cryosurgical catheter to be used in such an application must also have a relatively low operating pressure for safety reasons. It must have the cooling capacity to overcome the ambient heat load imposed by the circulating blood, yet it must be able to achieve a sufficiently low temperature to destroy the target tissue. Finally, the cold heat transfer element must be limited to the tip or end region of the catheter, in order to prevent the damaging of tissue other than the target tissue.
It is an object of the present invention to provide a miniature refrigeration system, including a flexible cryosurgical catheter, which can achieve an expanded gas temperature of at least as low as 183 K, with sufficient cooling power to maintain this temperature when a heat load is applied, and to perform this function with an inlet high pressure of no greater than 420 psia.